Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Primary Aldosteronism：a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 341
- 试验地点
- 2
- 主要终点
- Missing Diagnosis
研究概览
简要总结
To evaluate the effect of anti-hypertensive medication on efficiency of primary aldosteronism screening and confirmatory test, and to determine the appropriate diagnostic cutoff value for Chinese hypertension patients during antihypertensive drugs therapy.
详细描述
Aldosterone-Renin ratio (ARR)is currently the most reliable means available for screening for primary aldosterone（PA）while captopril challenging test is the widely used confirmatory test. However, some antihypertensive drugs may interfer aldosterone and renin levels. Thus, PA guidelines suggest that antihypertensive drugs should be withdraw or change therapy before screening.
But withdraw/changing the therapy is inconvenient for patients.
The investigators prepare to start a prospective study through recruiting hypertension patients, completing the ARR screening and captopril challenging test before and after withdraw/change therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent hypertension >150/100mmHg, including previously diagnosed grade 2 hypertension but well controlled by 1-2 drugs; newly diagnosed hypertension with 3 days blood pressure > 150 / 100mmHg
- •Resistant hypertension(combined with three antihypertensive drugs and one of them is diuretic but blood pressure is still greater than 140 / 90 mmHg ; or need to combined four anti-hypertensive drugs to control the blood pressure under 140 / 90 mmHg)
- •Family history of hypertension with early onset (< 40 years old)
- •Family history of hypertension with early onset (<40 years old) and cerebrovascular accident
- •Hypertension with spontaneous or diuretic hypokalemia
- •Hypertensive with adrenal incidentaloma
- •Hypertensive with OSAS
- •First-degree relatives of PA patients and with hypertension Stable antihypertensive medication therapy for more than 2 weeks, medication including：β-blockers, CCB, ACEi, ARB, MRA, and other diuretics.
排除标准
- •Patients hard to change or stop the medication for accomplish the screening test or diagnosis Unwilling to participate the study and refuse to sign on informed consent Patients who was diagnosed with other secondary hypertension Suspected with PA（rein concretion beyond the limit of normal reference range after stoping or changing the medication） Severe renal insufficiency （eGFR<30 ml/min/1.73m2）; pregnancy
结局指标
主要结局
Missing Diagnosis
时间窗: 2 weeks
essential hypertension turn to fit primary aldosteronism diagnosis after drug withdrawal
Misdiagnosis
时间窗: 2 weeks
primary aldosteronism turn to fit essential hypertension diagnosis after drug withdrawal.
Confirmation
时间窗: 2 weeks
Consistent diagnosis after drug withdrawal
次要结局
未报告次要终点
研究者
Qifu Li
Principal Investigator
Chongqing Medical University